Comparison of the Effects of LY2605541 and Insulin Glargine on Endogenous Glucose Output and Peripheral Glucose Disposal in Healthy Subjects and Patients With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Part B: Glucodynamics: Endogenous Glucose Output
研究概览
简要总结
LY2605541 is an investigational drug being developed for the treatment of diabetes mellitus. This study is designed to understand how the body handles the investigational drug, what effect this investigational drug has on the body, and how much should be given. This study will also measure how much of the investigational drug gets into the blood stream and how long it takes the body to get rid of it. The study has 2 parts: Part A will be conducted in healthy participants. Part B will be conducted in participants with type 1 diabetes mellitus (T1DM). This study will take approximately 10-14 days spread over 6-20 weeks, not including screening. Screening will be performed within 30 days of the start of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •All Participants
- •Are healthy males or participants with T1DM
- •Have a screening body mass index (BMI) of 20.0-29.9 kilograms per square meter (kg/m^2)
- •Healthy Participants ONLY
- •Are overtly healthy, as determined by medical history and physical examination
- •Have a fasting blood glucose <108 milligrams/deciliter (mg/dL) (6.0 millimoles/liter [mmol/L]) at screening
- •Participants with T1DM ONLY
- •Have a diagnosis of T1DM for at least 1 year based on medical history
- •Have a screening c-peptide <0.5 nanograms/milliliter (ng/mL)
- •Have a hemoglobin A1c (HbA1c) of 6.0 to 9.0% at screening
- •Have had no episodes of severe hypoglycemia in the past 6 months
排除标准
- •All Participants
- •Have a hemoglobin level <12.0 grams/deciliter (g/dL)
- •Are currently a smoker, used tobacco products on a regular basis in the 6 months prior to screening, or are intending to smoke during the study
- •Healthy Participants ONLY
- •Regular use or intended use of over-the counter or prescription medication within 7 and 14 days, respectively, prior to dosing (apart from vitamin/mineral supplements or occasional use of acetaminophen or ibuprofen).
- •Participants with T1DM ONLY
- •Regular use or intended use of any over-the-counter or prescription medications or nutritional supplements that affect blood glucose or the body's sensitivity to insulin or that promote weight loss within 14 days prior to dosing
- •Are receiving chronic (lasting longer than 14 consecutive days) systemic or inhaled glucocorticoid therapy (excluding topical, intra-articular, and intraocular preparations) or have received such therapy within the 4 weeks before dosing
- •Require a total daily insulin dose exceeding 100 units (U)
- •Have fasting triglycerides >400 mg/dL
研究组 & 干预措施
Part A, Cohort A; LY2605541
Healthy participants received 5.1 milliunits/minute (mU/min) in Period 1, 10.2 mU/min in Period 2, and 15.3 mU/min in Period 3, administered intravenously (IV) over 8 hours. All periods were separated by a minimum 6-day washout period
干预措施: LY2605541 (Drug)
Part A, Cohort A; Insulin Glargine
Healthy participants received insulin glargine (30 milliunits/meter squared/minute [mU/m^2/min]) administered IV over 8 hours in Period 4. All periods were separated by a minimum 6-day washout period
干预措施: Insulin glargine (Other)
Part A, Cohort B; LY2605541
Healthy participants received 15.3 mU/min in Period 1, 37.0 mU/min in Period 2, and 74.1 mU/min in Period 3, administered IV over 8 hours. All periods were separated by a minimum 6-day washout period.
干预措施: LY2605541 (Drug)
Part A, Cohort B; Insulin Glargine
Healthy participants received insulin glargine (60 mU/m^2/min) administered IV over 8 hours in Period 4. All periods were separated by a minimum 6-day washout period.
干预措施: Insulin glargine (Other)
Part B; LY2605541
Participants with T1DM received 15.3 mU/min in 1 of 4 study periods, administered IV up to 8 hours and received 74.1 mU/min in 1 of 4 Periods, administered IV up to 10 hours. Each dose was separated by a minimum 6-day washout period.
干预措施: LY2605541 (Drug)
Part B; Insulin Glargine
Participants with T1DM received 1 insulin glargine dose per study period (10 and 20 mU/m^2/min) administered IV over 8 hours in 2 of 4 study periods. Each dose was separated by a minimum 6-day washout period.
干预措施: Insulin glargine (Other)
结局指标
主要结局
Part B: Glucodynamics: Endogenous Glucose Output
时间窗: Baseline, up to 10 hours (duration of the euglycemic glucose clamp)
The percent suppression from baseline in endogenous glucose production (EGP) is presented. Percent EGP change from baseline was calculated by (1-\[last 2 hours of EGP/basal EGP\])\*100. The duration of the clamp procedure was 10 hours for the LY2605541 74.1 mU/min dose in Part B. The duration of the clamp procedures performed at the 15.3 mU/min LY2605541 dose and both of the insulin glargine doses was 8 hours.
Part B: Glycodynamics: Maximum Rate of Glucose Disposal
时间窗: Baseline, up to 10 hours (duration of the euglycemic glucose clamp)
The maximum rate of glucose disposal (Rdmax) is presented. The duration of the clamp procedure was 10 hours for the LY2605541 74.1 mU/min dose in Part B. The duration of the clamp procedures performed at the 15.3 mU/min LY2605541 dose and both of the insulin glargine doses was 8 hours.
Part B: Glycodynamics: Glucose Disposal
时间窗: Baseline, up to 10 hours (duration of the euglycemic glucose clamp)
The fold change from baseline in glucose disappearance rate (GDR) is presented. The fold GDR increase from baseline was calculated by last 2 hours of GDR/basal GDR. The duration of the clamp procedure was 10 hours for the LY2605541 74.1 mU/min dose in Part B. The duration of the clamp procedures performed at the 15.3 mU/min LY2605541 dose and both of the insulin glargine doses was 8 hours.
次要结局
未报告次要终点